FDA 510(k)

CREATINE KINASE REAGENT

K-Number: K803301 · 1981-01-16

Decision Date1981-01-16

Product CodeCGS

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

CREATINE KINASE REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Gilford Diagnostics. It received FDA 510(k) clearance on 1981-01-16 under 510(k) number K803301. The device is classified under product code CGS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CREATINE KINASE REAGENT?

CREATINE KINASE REAGENT is a medical device that received FDA 510(k) clearance on 1981-01-16. The listed applicant is Gilford Diagnostics. The 510(k) number is K803301.

When did CREATINE KINASE REAGENT receive FDA 510(k) clearance?

CREATINE KINASE REAGENT received FDA 510(k) clearance on 1981-01-16, under 510(k) number K803301.

Who is the listed applicant for CREATINE KINASE REAGENT?

The FDA 510(k) record lists Gilford Diagnostics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CREATINE KINASE REAGENT?

The FDA product code for CREATINE KINASE REAGENT is CGS.

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Other records listing Gilford Diagnostics as applicant

K832094BILIRUBIN CALIBRATORS & CONTROL K831844DIRECT BILIRUBIN REAGENT K831843GILCHEM TOTAL BILIRUBIN REAGENT K823709TRIGLYCERIDE REAGENT (UV)K822739AHBD K822334BILIRUBIN CALIBRATORS

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Related Devices (Code: CGS)

K191296Pointe Scientific Creatinine Kinase (CK) Reagent SetMedtest DX K182702SEKURE Creatine Kinase AssaySekisui Diagnostics P.E.I., Inc.K160724ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3 CalibratorSiemens Healthcare Diagnostics, Inc.K123977RANDOX LIQUID CK-MB, RANDOX CK-MB CALIBRATORRandox Laboratories, Ltd.K112416CPK REAGENTVital Diagnostics (Manufacturing) Ptyltd K083465DIMENSION VISTA CREATINE KINASE FLEX REAGENT CARTRIDGE AND DIMENSION VISTA CREATINE KINASE MB FLEX REAGENT CARTRIDGESiemens Healthcare Diagnostics

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.